Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: lithium (mood stabilizer)

Drug: divalproex (mood stabilizer)

Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00081380

D1447C00127

Details and patient eligibility

About

The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Open-Label

A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
Able to understand and comply with the requirements of the study.

Exclusion criteria

Open-Label

Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
Previously randomized into this study or D1447C00126